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OpenTrials
Completed

NCT Number: NCT00933556

A Pilot Trial to Determine the Efficacy of VSL#3 for Reducing Colonization by VRE

The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, VSL#3 versus oral placebo for reducing colonization by VRE.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of wisconsin hospital

Madison, Wisconsin, 53792, United States

About this study

Healthcare-associated infections are an important threat to patient safety. Currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the United States, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. Seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as vancomycin-resistant enterococcus (VRE), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential.

Eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. No effective means of eradicating VRE intestinal colonization exist.

Probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. Even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as VRE.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • subjects will be male or female
  • 18 years of age or older
  • may or may not be hospitalized
  • able to take oral medications
  • have been found to be colonized with VRE or at high risk of being colonized by VRE and are not taking antibiotics

Exclusion criteria

  • people on antibiotics will not be eligible to participate

Treatment and study plan

VSL#3

Dietary Supplement

6 gms of powder formulation to be given once a day for 4 weeks

Other names: yoplait, activia

Sugar pill (placebo)

Dietary Supplement

placebo identical to the active product will be given

Other names: splenda

Primary outcomes

  1. The main outcomes will be the proportion of patients colonized with VRE at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.

    Time frame: 24 weeks

Secondary outcomes

  1. Incidence of clinical infections will be assessed in the one year following enrollment into the study.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, VSL#3 for Reducing Colonization by Vancomycin-resistant Enterococcus (VRE)

Acronym: PROVE

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Jul 7, 2009
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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